Methods | Randomized feasibility study | |
Participants | 897 women undergoing evaluation for fetal well-being. | |
Interventions | Doppler (umbilical artery resistance index) or FHR testing (computerised FHR monitoring and numerical analysis on-line) | |
Outcomes | Reasons for delivery, method of delivery, gestational age, birthweight, 5-minute Apgar score < 7, perinatal mortality, special care nursery | |
Notes | ||
Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Computer-generated algorithm based on hospital number. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) All outcomes |
High risk | Not blinded. |
Blinding of outcome assessment (detection bias) All outcomes |
High risk | Not blinded. |
Incomplete outcome data (attrition bias) All outcomes |
Low risk | Appears to be no loss to follow-up according to data presented in table 2 and 3 - patient numbers add up to 438 for Doppler group and 459 for FHR group - so all patients accounted for from 897 initially referred |
Selective reporting (reporting bias) | Unclear risk | Unclear - not clearly documented which outcomes were to be collected as part of the study |
Other bias | Low risk | “The two groups were well-matched for the baseline variables measured.” |